Trial Outcomes & Findings for Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1) (NCT NCT05467293)
NCT ID: NCT05467293
Last Updated: 2024-07-30
Results Overview
Modified National Eye Institute Scale; 0-20: Higher is Worse
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
Day 85
Results posted on
2024-07-30
Participant Flow
Participant milestones
| Measure |
0.3% YP-P10 Ophthalmic Solution
Participants enrolled in 0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution group
|
1% YP-P10 Ophthalmic Solution
Participants enrolled in 1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution group
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
Participants enrolled in YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle) group
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
86
|
|
Overall Study
COMPLETED
|
77
|
81
|
84
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)
Baseline characteristics by cohort
| Measure |
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
86 participants
n=7 Participants
|
86 participants
n=5 Participants
|
257 participants
n=4 Participants
|
|
Ethnicity
Hispanic or Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Iris Color (OD)
Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Iris Color (OD)
Blue
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Iris Color (OD)
Brown
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Iris Color (OD)
Hazel
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Iris Color (OD)
Green
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Iris Color (OD)
Gray
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Iris Color (OD)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Iris Color (OS)
Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Iris Color (OS)
Blue
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Iris Color (OS)
Brown
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Iris Color (OS)
Hazel
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Iris Color (OS)
Green
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Iris Color (OS)
Gray
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Iris Color (OS)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 85Modified National Eye Institute Scale; 0-20: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Total Corneal Fluorescein Staining
|
7.35 score on a scale
Standard Deviation 1.730
|
7.25 score on a scale
Standard Deviation 1.957
|
7.12 score on a scale
Standard Deviation 1.850
|
PRIMARY outcome
Timeframe: Day 85Visual Analogue Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Ocular Discomfort Score
|
52.8 score on a scale
Standard Deviation 24.77
|
54.2 score on a scale
Standard Deviation 27.17
|
53.6 score on a scale
Standard Deviation 26.40
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Fluorescein Staining: Inferior
|
1.71 score on a scale
Standard Deviation 0.379
|
1.71 score on a scale
Standard Deviation 0.471
|
1.73 score on a scale
Standard Deviation 0.507
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Fluorescein Staining: Superior
|
1.34 score on a scale
Standard Deviation 0.516
|
1.36 score on a scale
Standard Deviation 0.537
|
1.26 score on a scale
Standard Deviation 0.519
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Fluorescein Staining: Central
|
1.33 score on a scale
Standard Deviation 0.535
|
1.28 score on a scale
Standard Deviation 0.543
|
1.29 score on a scale
Standard Deviation 0.545
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Fluorescein Staining: Temporal
|
1.36 score on a scale
Standard Deviation 0.501
|
1.33 score on a scale
Standard Deviation 0.570
|
1.29 score on a scale
Standard Deviation 0.444
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Fluorescein Staining: Nasal
|
1.60 score on a scale
Standard Deviation 0.548
|
1.57 score on a scale
Standard Deviation 0.655
|
1.55 score on a scale
Standard Deviation 0.542
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-24: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Lissamine Green Staining: Conjunctival Sum
|
5.36 score on a scale
Standard Deviation 3.922
|
4.96 score on a scale
Standard Deviation 3.872
|
5.62 score on a scale
Standard Deviation 3.848
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Lissamine Green Staining: Inferior Temporal
|
0.83 score on a scale
Standard Deviation 0.754
|
0.76 score on a scale
Standard Deviation 0.680
|
0.95 score on a scale
Standard Deviation 0.695
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4 Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Lissamine Green Staining: Superior Temporal
|
0.76 score on a scale
Standard Deviation 0.689
|
0.66 score on a scale
Standard Deviation 0.700
|
0.76 score on a scale
Standard Deviation 0.723
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4 Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Lissamine Green Staining: Temporal
|
0.88 score on a scale
Standard Deviation 0.747
|
0.81 score on a scale
Standard Deviation 0.802
|
0.93 score on a scale
Standard Deviation 0.760
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4 Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Lissamine Green Staining: Inferior Nasal
|
0.92 score on a scale
Standard Deviation 0.751
|
0.94 score on a scale
Standard Deviation 0.775
|
1.11 score on a scale
Standard Deviation 0.733
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4 Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Lissamine Green Staining: Superior Nasal
|
0.94 score on a scale
Standard Deviation 0.799
|
0.86 score on a scale
Standard Deviation 0.830
|
0.88 score on a scale
Standard Deviation 0.818
|
SECONDARY outcome
Timeframe: 13 weeksModified National Eye Institute Scale; 0-4 Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Lissamine Green Staining: Nasal
|
1.04 score on a scale
Standard Deviation 0.862
|
0.93 score on a scale
Standard Deviation 0.810
|
0.99 score on a scale
Standard Deviation 0.799
|
SECONDARY outcome
Timeframe: 13 weeksOra Calibra Scale; 0-4 Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Conjunctival Redness
|
1.87 score on a scale
Standard Deviation 0.619
|
1.87 score on a scale
Standard Deviation 0.655
|
1.94 score on a scale
Standard Deviation 0.639
|
SECONDARY outcome
Timeframe: 13 weeksscore on a scale of ≤ 10 mm/5 minutes and ≥ 1 mm/5 minutes in at least one eye. Schirmer's test can be interpreted as follows: 0 to 5 mm: extremely dry eyes; 5 to 10 mm: moderately dry eyes; 10 to 15 mm: possible dry eyes; Longer than 15 mm: normal tear function.
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Unanesthetized Schirmer's Test
|
5.2 mm
Standard Deviation 2.82
|
5.0 mm
Standard Deviation 2.76
|
4.7 mm
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: 13 weeksOutcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Tear Film Break-up Time (TFBUT)
|
2.598 seconds
Standard Deviation 0.8443
|
2.540 seconds
Standard Deviation 0.9201
|
2.441 seconds
Standard Deviation 0.8812
|
SECONDARY outcome
Timeframe: 13 weeksOcular Surface Disease Index Scale 0-100 (higher is worse)
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Ocular Surface Disease Index (OSDI): Subtotal 1-5
|
37.44 score on a scale
Standard Deviation 19.804
|
37.71 score on a scale
Standard Deviation 21.555
|
37.50 score on a scale
Standard Deviation 17.485
|
SECONDARY outcome
Timeframe: 13 weeksOcular Surface Disease Index Scale 0-100 (higher is worse)
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Ocular Surface Disease Index (OSDI): Subtotal 6-9
|
39.29 score on a scale
Standard Deviation 24.653
|
40.34 score on a scale
Standard Deviation 27.580
|
35.75 score on a scale
Standard Deviation 22.152
|
SECONDARY outcome
Timeframe: 13 weeksOcular Surface Disease Index Scale 0-100 (higher is worse)
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Ocular Surface Disease Index (OSDI): Subtotal 10-12
|
55.86 score on a scale
Standard Deviation 27.538
|
49.26 score on a scale
Standard Deviation 27.346
|
55.53 score on a scale
Standard Deviation 26.114
|
SECONDARY outcome
Timeframe: 13 weeksOcular Surface Disease Index Scale 0-100 (higher is worse)
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Ocular Surface Disease Index (OSDI): Total
|
42.49 score on a scale
Standard Deviation 19.426
|
41.46 score on a scale
Standard Deviation 20.031
|
41.42 score on a scale
Standard Deviation 17.098
|
SECONDARY outcome
Timeframe: 13 weeksVisual Analog Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Burning/Stinging
|
34.5 score on a scale
Standard Deviation 25.56
|
37.9 score on a scale
Standard Deviation 28.33
|
43.3 score on a scale
Standard Deviation 26.48
|
SECONDARY outcome
Timeframe: 13 weeksVisual Analog Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Itching
|
38.5 score on a scale
Standard Deviation 25.05
|
44.2 score on a scale
Standard Deviation 28.09
|
40.9 score on a scale
Standard Deviation 25.50
|
SECONDARY outcome
Timeframe: 13 WeeksVisual Analog Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Foreign Body Sensation
|
38.8 score on a scale
Standard Deviation 27.62
|
40.2 score on a scale
Standard Deviation 28.63
|
40.6 score on a scale
Standard Deviation 28.46
|
SECONDARY outcome
Timeframe: 13 WeeksVisual Analog Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Blurred Vision
|
41.2 score on a scale
Standard Deviation 27.90
|
45.0 score on a scale
Standard Deviation 28.89
|
41.5 score on a scale
Standard Deviation 26.62
|
SECONDARY outcome
Timeframe: 13 WeeksVisual Analog Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Eye Dryness
|
61.2 score on a scale
Standard Deviation 24.50
|
65.3 score on a scale
Standard Deviation 23.51
|
60.4 score on a scale
Standard Deviation 23.42
|
SECONDARY outcome
Timeframe: 13 WeeksVisual Analog Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Photophobia
|
44.9 score on a scale
Standard Deviation 27.70
|
47.1 score on a scale
Standard Deviation 29.82
|
44.0 score on a scale
Standard Deviation 29.57
|
SECONDARY outcome
Timeframe: 13 WeeksVisual Analog Scale; 0-100: Higher is Worse
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Pain in Eyes
|
30.5 score on a scale
Standard Deviation 27.26
|
28.2 score on a scale
Standard Deviation 25.64
|
33.6 score on a scale
Standard Deviation 28.10
|
SECONDARY outcome
Timeframe: 13 weeksSelf-Administrating with use of Daily Compliance Diary. Subject daily diaries were collected at Visits 1 through 6, and the subject's used and unused study drug ampules were collected at Visit 3 through 6. Dosing compliance was based on the used and unused ampule count. If the subject was less than 80% or more than 125% compliant with dosing based on the expected number of used ampules, then the subject was deemed noncompliant and a dosing deviation was recorded. Dosing compliance (% compliance) was assessed by calculating the number of actual doses received and comparing that to the number of expected doses as follows: Compliance (%) = Number of Actual Doses Received / Number of Expected Doses x 100% The number of expected doses that will be used for calculating compliance was calculated as: 2 x \[(Date of Last Dose - Date of First Dose) + 1\]
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Treatment Compliance Using a Daily Compliance Diary
|
114.90 percentage of compliance
Standard Deviation 134.816
|
100.13 percentage of compliance
Standard Deviation 4.525
|
100.83 percentage of compliance
Standard Deviation 8.480
|
SECONDARY outcome
Timeframe: 13 weeksA drop comfort evaluation will be performed immediately upon administration of study drug and then at 1, 2, and 3 minutes following initial dosing using the Ora Calibra Drop Comfort Scale
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=172 Eyes
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=170 Eyes
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=172 Eyes
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Drop Comfort - Positive Response
|
89.5 percentage of comfort
Interval 0.0 to 100.0
|
84.7 percentage of comfort
Interval 0.0 to 100.0
|
84.9 percentage of comfort
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 13 weeksVisual Acuity was assessed using an ETDRS chart
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 weeksSlit lamp biomicroscopic observations will be graded as Normal or Abnormal
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 weeksEach subject will be queried regarding adverse events
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Adverse Event Query - TEAEs
|
21 Participants
|
24 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 13 WeeksEach subject will be queried regarding adverse events
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Adverse Event Query - Ocular TEAEs
|
12 Participants
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 13 WeeksEach subject will be queried regarding adverse events
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Adverse Event Query - Non Ocular TEAEs
|
11 Participants
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 13 WeeksEach subject will be queried regarding adverse events
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 13 WeeksEach subject will be queried regarding adverse events
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Adverse Event Query - TEAEs Suspected to be Related to Study Drug
Definitely related to study drug
|
8 Participants
|
5 Participants
|
5 Participants
|
|
Adverse Event Query - TEAEs Suspected to be Related to Study Drug
Probably related to study drug
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Adverse Event Query - TEAEs Suspected to be Related to Study Drug
Possibly related to study drug
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Adverse Event Query - TEAEs Suspected to be Related to Study Drug
No TEAE Reported
|
75 Participants
|
77 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 13 WeeksEach subject will be queried regarding adverse events
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Adverse Event Query - SEA Reported
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 13 weeksusing indirect ophthalmoscopy. The Investigator will make observations of the vitreous, retina, macula, choroid and optic nerve.
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 weeksA single measurement is made
Outcome measures
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 Participants
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 Participants
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 Participants
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
1% YP-P10 Ophthalmic Solution
Serious events: 1 serious events
Other events: 28 other events
Deaths: 1 deaths
0.3% YP-P10 Ophthalmic Solution
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
YP-P10 Placebo Ophthalmic Solution (Vehicle)
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 participants at risk
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 participants at risk
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 participants at risk
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
Cardiac disorders
Serious Adverse Event
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
General disorders
Serious Adverse Event
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
Other adverse events
| Measure |
1% YP-P10 Ophthalmic Solution
n=86 participants at risk
1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
0.3% YP-P10 Ophthalmic Solution
n=85 participants at risk
0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
|
YP-P10 Placebo Ophthalmic Solution (Vehicle)
n=86 participants at risk
YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
|
|---|---|---|---|
|
General disorders
Instillation Eye Pain
|
11.6%
10/86 • Number of events 10 • 13 Weeks
|
4.7%
4/85 • Number of events 4 • 13 Weeks
|
10.5%
9/86 • Number of events 9 • 13 Weeks
|
|
Eye disorders
Visual acuity reduced
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
3.5%
3/85 • Number of events 3 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
2.3%
2/86 • Number of events 2 • 13 Weeks
|
|
Eye disorders
Acquired hypertrophy of the retinal pigment epithelium
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Eye disorders
Blindness
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Eye disorders
Corneal infiltrates
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Eye disorders
Eyelid myokymia
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Eye disorders
Visual Impairment
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Infections and infestations
Hordeolum
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Conjunctival abrasion
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Infections and infestations
COVID-19
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
2.4%
2/85 • Number of events 2 • 13 Weeks
|
3.5%
3/86 • Number of events 3 • 13 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
3.5%
3/85 • Number of events 3 • 13 Weeks
|
2.3%
2/86 • Number of events 2 • 13 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
2.3%
2/86 • Number of events 2 • 13 Weeks
|
|
Infections and infestations
Tooth abscess
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Infections and infestations
Periodontitis
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Infections and infestations
Sinusitis
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/86 • 13 Weeks
|
3.5%
3/85 • Number of events 3 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Contision
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Musculoskeletal and connective tissue disorders
Intravertebral disc degeneration
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Nervous system disorders
Headache
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Psychiatric disorders
Depression
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Psychiatric disorders
Respiratory, thoracic, and mediastinal disorders
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Psychiatric disorders
Oropharyngeal pain
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/86 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/86 • Number of events 1 • 13 Weeks
|
0.00%
0/85 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/86 • 13 Weeks
|
1.2%
1/85 • Number of events 1 • 13 Weeks
|
0.00%
0/86 • 13 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place